MedTrace Logo

JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan

NCT07384377 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-02-03

No results posted yet for this study

Summary

The study is being conducted to evaluate the efficacy and safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan subjects.

Conditions

Interventions

DRUG

Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib.

TAS-102(35 mg/m2, maximum 80 mg per dose), twice daily (BID), once every 4 weeks (Q4W); or Regorafenib 160mg, once daily (QD), once every 4 weeks (Q4W); or Fruquintinib 5mg once daily (QD), once every 4 weeks (Q4W).

DRUG

JSKN003

JSKN003 (6.3 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W).

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2027-11-30
Completion
2028-06-15

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07384377 on ClinicalTrials.gov